EP3285825B1 - Method and device for producing a medical solution - Google Patents
Method and device for producing a medical solution Download PDFInfo
- Publication number
- EP3285825B1 EP3285825B1 EP16720711.7A EP16720711A EP3285825B1 EP 3285825 B1 EP3285825 B1 EP 3285825B1 EP 16720711 A EP16720711 A EP 16720711A EP 3285825 B1 EP3285825 B1 EP 3285825B1
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- Prior art keywords
- conductivity
- mixed solution
- modulation
- component
- measured
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- 238000000034 method Methods 0.000 title claims description 13
- 239000008155 medical solution Substances 0.000 title claims description 11
- 239000011259 mixed solution Substances 0.000 claims description 71
- 230000002596 correlated effect Effects 0.000 claims description 29
- 239000012141 concentrate Substances 0.000 claims description 15
- 238000011156 evaluation Methods 0.000 claims description 11
- 238000005259 measurement Methods 0.000 claims description 9
- 230000010363 phase shift Effects 0.000 claims description 6
- 239000000385 dialysis solution Substances 0.000 claims description 5
- 239000008280 blood Substances 0.000 claims description 3
- 210000004369 blood Anatomy 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 3
- 239000002253 acid Substances 0.000 claims description 2
- 238000000502 dialysis Methods 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 230000000638 stimulation Effects 0.000 claims 2
- 239000000243 solution Substances 0.000 description 6
- 230000005284 excitation Effects 0.000 description 5
- 230000002378 acidificating effect Effects 0.000 description 4
- 230000001186 cumulative effect Effects 0.000 description 3
- 230000001447 compensatory effect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000001631 haemodialysis Methods 0.000 description 2
- 230000000322 hemodialysis Effects 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000002123 temporal effect Effects 0.000 description 2
- 238000009529 body temperature measurement Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 230000000875 corresponding effect Effects 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000002357 osmotic agent Substances 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1603—Regulation parameters
- A61M1/1605—Physical characteristics of the dialysate fluid
- A61M1/1607—Physical characteristics of the dialysate fluid before use, i.e. upstream of dialyser
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/166—Heating
- A61M1/1664—Heating with temperature control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
- A61M1/287—Dialysates therefor
-
- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05D—SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
- G05D11/00—Control of flow ratio
- G05D11/02—Controlling ratio of two or more flows of fluid or fluent material
- G05D11/13—Controlling ratio of two or more flows of fluid or fluent material characterised by the use of electric means
- G05D11/135—Controlling ratio of two or more flows of fluid or fluent material characterised by the use of electric means by sensing at least one property of the mixture
- G05D11/138—Controlling ratio of two or more flows of fluid or fluent material characterised by the use of electric means by sensing at least one property of the mixture by sensing the concentration of the mixture, e.g. measuring pH value
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
- A61M2205/702—General characteristics of the apparatus with testing or calibration facilities automatically during use
Definitions
- the present invention relates to a method and an apparatus for producing a medical solution from at least one first and at least one second liquid component, wherein the first component and the second component are each conveyed with at least one conveying means in order to obtain at least one mixed solution.
- the concentrations of the components are usually detected by individual conductivity sensors, so that a deviation from the respective setpoint independent of the sum concentration, ie from the concentration of the mixed solution containing the components can be detected.
- the EP 2 494 998 A1 discloses an apparatus for manufacturing a medical solution having all the features of the preamble of claim 1.
- a disadvantage of this known procedure is that a sensor cell is required for each component. Possibly. is used as a further protection system, another sensor cell for measuring the conductivity of the mixed solution, so that the overall result is a comparatively complex structure.
- the present invention has for its object to simplify a method and an apparatus for producing a medical solution and in particular a dialysis solution, as used for example in hemodialysis, compared to the prior art.
- the conveying means are operated such that a modulation of the concentration of the first and the second component takes place and that measured at least one, preferably at exactly one measuring point, the conductivity of the mixed solution or a correlated with the conductivity parameters of the mixed solution is, wherein the modulation of the concentrations in a desired state such that a certain modulation (target modulation) or no modulation of the measured conductivity of the mixed solution or the conductivity-correlated parameter of the mixed solution occurs.
- the present invention is therefore based on the idea to promote the components, such as the basic concentrate and the acidic concentrate so that the concentrations of the first component and the second component in the mixed solution are variable over time.
- This modulation of the at least two components can be made such that the sum conductivity or the sum concentration correlated therewith, i. the conductivity or concentration of the mixed solution has no modulation, i. is constant in time or has a very specific desired modulation.
- an error condition e.g. the sum concentration of the mixed solution found that this is modulated or deviates in terms of their modulation from the specific target modulation, can be concluded that an error condition. This may be, for example, that one or both components are present in the mixed solution at too high or too low a concentration.
- the modulation of the concentrations of the first and the second solution is carried out in such a way that no temporal variations in the conductivity or the concentration or a parameter correlated therewith occur in the mixed solution. If, in deviation from this nominal state, it is determined that the conductivity or a parameter correlated therewith is modulated, i. is not constant over time, can be concluded that an error condition.
- an evaluation of the measured value of the mixed solution can be made as to whether there is a modulation of this value. If this is the case, an error condition can be concluded.
- the invention can be inferred from the type of fault condition on the component whose concentration deviates from the expected value.
- a fault condition i. closed on a different state from the desired state, but it can be determined which of the several components is present in a concentration that deviates from the desired value.
- the present invention is not limited to the use of exactly two solutions for producing a mixed solution, but that more than two solutions can be used.
- the mixed solution may be the ready-to-use, administrable medical solution, in particular dialysis solution, or even a solution which becomes the finished medical solution, in particular dialysis solution, only after the addition of one or more further substances.
- the method according to the invention can be carried out while the patient is not connected to the device for producing the solution.
- the invention also includes the case that the method is carried out in the sense of an online preparation of the solution while the patient is connected to the device.
- the first component may be a basic concentrate and the second component may be an acidic concentrate.
- the basic concentrate has a pH of> 7 and a buffer
- the acidic concentrate has a pH of ⁇ 7 and a physiologically acceptable acid.
- One or both of the concentrates may contain electrolytes and optionally an osmotic agent.
- the present invention allows the monitoring of the physiological properties of the partial components with a single conductivity cell or with a single sensor used to measure the concentration or a is suitable with this or with the conductivity correlated parameter.
- this cell or the sensor can be used to monitor the conductivity or the concentration of the mixed solution.
- an advantageous embodiment of the invention is that no measurement of the conductivity or a correlated with the conductivity parameter of the first or the second component is made, but only the detection of a parameter, in particular the conductivity of the mixed solution.
- no serial delivery of the components is provided at the measuring point, since in a preferred embodiment of the invention the faulty component can be deduced from the measured property of the mixed solution.
- the excitation of the actuator or the conveying means for the component is detected, which / is preferably designed as a pump.
- the modulation of the concentrations of the first and second components is sinusoidal.
- the present invention further relates to a device for producing a medical solution, wherein the device has at least one first conveying means for conveying a first component and at least one second conveying means for conveying a second component and at least one main line, which is in communication with the conveying means in that the components are conveyed by the conveying means into the main line so that at least one mixed solution is formed in the main line, at least one, preferably exactly one, sensor for measuring the conductivity or a parameter of the mixed solution correlated with the conductivity being provided in the main line and that the conveying means are designed so that a modulation of the concentrations in a nominal state of the device takes place in such a way that a certain desired modulation or no modulation of the measured conductivity of the mixed solution or with the Leitf ability correlated measured parameter of the mixed solution occurs.
- the device has at least one evaluation unit, which is in communication with the sensor and which evaluates the signal detected by the sensor, wherein the evaluation unit is designed such that an error state is concluded when a modulation or one of the desired modulation deviating modulation of the measured conductivity of the mixed solution or of the conductivity-correlated measured parameter of the mixed solution is detected.
- the evaluation unit may be designed in such a way that it is possible to determine from the type of error state which component deviates from the expected value in terms of its concentration.
- Sensors for measuring the individual conductivity or a conductivity-correlated individual parameter of the first or the second component are preferably dispensed with.
- the evaluation unit is preferably designed such that from the amplitude of the modulation of the measured conductivity or of the parameter correlated with the conductivity and / or from the average measured conductivity or from the mean value of the parameter correlated with the conductivity and / or from the phase shift of the modulation measured conductivity or the correlated with the conductivity parameter with respect to the excitation of the conveyor is determined, which component differs in concentration from the expected value for this component.
- a corresponding sensor or other detection means is provided which controls this modulation, i. detects the excitation of the pump or the like.
- the modulation of the concentration of the first and the second component is sinusoidal.
- the present invention further relates to a blood treatment device, in particular a dialysis machine, preferably for performing a hemodialysis treatment, wherein the blood treatment device comprises at least one device according to the invention for the preparation of the medical solution.
- FIG. 1 is the schematic time course of the Summenleitrus 100, ie the conductivity of the composite of the components A and B mixed solution over time visible. Furthermore, the time profiles of the conductivities of the components A and B (LF component A, LF component B) are shown such that the value for the conductivity of the component B (shown in dashed lines) is added to the value of the conductivity of the component A, see above that results in a temporally constant sum conductivity 100.
- the embodiment relates to the measurement of the conductivity and is also conceivable for the measurement of any other parameter.
- the invention thus also encompasses the measurement of each other parameter of the mixed solution, which correlates with the conductivity or with the concentration, so that a conclusion can be drawn on the concentration of the components A and / or B or on their ingredients.
- FIG. 1 It can be seen that the pump delivery of the components A and B is modulated in such a way that the sum conductivity 100 of the mixture has no modulation, ie is constant in time.
- the sum concentration, which is correlated with the sum conductivity, is therefore constant over time, whereas the concentrations of the components A and B in the mixed solution of both components vary over time.
- the amplitude of the concentration or conductivity variations which in FIG. 1 is identical, is identical for the two components A and B.
- the relative amplitude is the quotient of the absolute amplitude of the concentration fluctuation and the mean value of the concentration of component A or B in the mixed solution.
- the relative amplitude f A of the component A results directly from the desired ratio of the concentrations of the components B and A in the mixed solution and the relative amplitude f B of the component B.
- the expected values C A and C B in the mixed solution are constant in time, so that there is also a temporal constancy with regard to the sum conductivity LF A (t) + LF B (t).
- the sum conductivity is modulated.
- a certain modulation of the sum conductivity is generated, ie the measurement of the Total conductivity produces a characteristic fingerprint.
- it can be determined based on the measurement of the sum conductivity, which component deviates from the expected value.
- the mean sum conductivity corresponds or correlates in this case with C A + 1 / ⁇ C B.
- the conductivity of the sum concentration ie the mixed solution of the two components A and B modulates in this embodiment with the amplitude (1 - 1 / ⁇ ) C B / second
- the mean sum conductivity corresponds or correlates with 1 / ⁇ C A + C B in this case.
- the average conductivity, its amplitude, and the phase versus actuator excitation of the component promotion identify the component whose concentration deviates from the expected value.
- FIG. 2 shows in the state A the case that the expected values of the contributions of the components A and B is reached.
- the sum conductivity 100 or the sum concentration of the mixed solution shows no modulation, ie is constant over time.
- Reference numerals 10 and 20 indicate the time course of the contributions of the conductivity or the concentration of the partial components A. (Reference 10) and B (Reference 20) for conductivity 100 or concentration of the mixed solution.
- the expected value 10 of the component A is reached, but the actual value of the concentration 20 of the component B is below the expected value.
- the sum conductivity 100 or the sum concentration is below the expected value and is phase-shifted modulated with the deviating component B.
- the sum conductivity 100 or the sum concentration is modulated, i. not constant in time.
- a deviation of the concentration contributions of the components A and B can thus be made from the analysis of the modulated sum concentration or sum conductivity.
- the mean expected value of the sum concentration or the sum conductivity indicates an over or under promotion of the deviating component, i. the measured average of the sum conductivity or the sum concentration indicates an over- or under-promotion of the deviating component.
- FIG. 3 shows a multi-component system with modulated promotion of the concentrations of components 1 to N. All components are conveyed in a main line H, in which the only conductivity cell (LF cell) is located.
- the respective modulations are characteristic of each component in terms of frequency and phase. This characteristic allows an identification of the contribution deviating from the expected value of a component.
- the partial components for monitoring the contributions of the individual, i. the partial components only a single or a single conductivity or concentration sensor or the like required.
- the components are added via modulated conveying concentrate pumps to the main line, in which the sensor is located.
- any other sensor can be used, which inferences on the concentrations or Leiinateen the components or on the cumulative concentration or on the total conductivity allowed.
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Description
Die vorliegende Erfindung betrifft ein Verfahren und eine Vorrichtung zur Herstellung einer medizinischen Lösung aus wenigstens einer ersten und wenigstens einer zweiten flüssigen Komponente, wobei die erste Komponente und die zweite Komponente mit jeweils wenigstens einem Fördermittel gefördert werden, um zumindest eine Mischlösung zu erhalten.The present invention relates to a method and an apparatus for producing a medical solution from at least one first and at least one second liquid component, wherein the first component and the second component are each conveyed with at least one conveying means in order to obtain at least one mixed solution.
Aus dem Stand der Technik ist es bekannt, Dialyselösungen aus zwei Komponenten herzustellen, von denen die eine ein saures und die andere ein basisches Konzentrat ist. Beide Komponenten müssen in ihrer Konzentration überwacht werden. Dies erfolgt bei bekannten Geräten dadurch, dass für jede der Komponenten ein Leitfähigkeitssensor in Verbindung mit einer Temperaturmessung zur Berücksichtigung der Temperaturabhängigkeit der Leitfähigkeit vorgesehen ist.From the prior art it is known to prepare dialysis solutions from two components, one of which is an acidic and the other a basic concentrate. Both components must be monitored in their concentration. This is done in known devices in that for each of the components, a conductivity sensor is provided in conjunction with a temperature measurement to take into account the temperature dependence of the conductivity.
Die Förderung der Komponenten, d.h. der Konzentrate erfolgt mittels Konzentratpumpen. Weichen die ermittelten Leitfähigkeitswerte von Sollwerten ab, erfolgt ein Gerätealarm.The promotion of the components, i. Concentrates are carried out by means of concentrate pumps. If the determined conductivity values deviate from setpoints, a device alarm occurs.
Wie ausgeführt, werden die Konzentrationen der Komponenten, im Folgenden auch als "partielle Komponenten" bezeichnet, üblicherweise durch einzelne Leitfähigkeitssensoren erfasst, so dass eine Abweichung vom jeweiligen Sollwert unabhängig von der Summenkonzentration, d.h. von der Konzentration der die Komponenten enthaltenden Mischlösung erfasst werden kann.As stated, the concentrations of the components, hereinafter also referred to as "partial components", are usually detected by individual conductivity sensors, so that a deviation from the respective setpoint independent of the sum concentration, ie from the concentration of the mixed solution containing the components can be detected.
Die
Ein Nachteil dieser bekannten Vorgehensweise besteht darin, dass für jede Komponente eine Sensorzelle benötigt wird. Ggf. wird als weiteres Schutzsystem eine weitere Sensorzelle zur Messung der Leitfähigkeit der Mischlösung eingesetzt, so dass sich insgesamt ein vergleichsweise komplexer Aufbau ergibt.A disadvantage of this known procedure is that a sensor cell is required for each component. Possibly. is used as a further protection system, another sensor cell for measuring the conductivity of the mixed solution, so that the overall result is a comparatively complex structure.
Der vorliegenden Erfindung liegt die Aufgabe zugrunde, ein Verfahren und eine Vorrichtung zur Herstellung einer medizinischen Lösung und insbesondere einer Dialyselösung, wie sie beispielsweise bei der Hämodialyse zum Einsatz kommt, gegenüber dem Stand der Technik zu vereinfachen.The present invention has for its object to simplify a method and an apparatus for producing a medical solution and in particular a dialysis solution, as used for example in hemodialysis, compared to the prior art.
Diese Aufgabe wird durch ein Verfahren mit den Merkmalen des Anspruchs 1 und durch eine Vorrichtung mit den Merkmalen des Anspruchs 7 gelöst.This object is achieved by a method having the features of
Erfindungsgemäß ist unter anderem vorgesehen, dass die Fördermittel derart betrieben werden, dass eine Modulation der Konzentration der ersten und der zweiten Komponente erfolgt und dass an wenigstens einer, vorzugsweise an genau einer Messstelle die Leitfähigkeit der Mischlösung oder ein mit der Leitfähigkeit korrelierter Parameter der Mischlösung gemessen wird, wobei die Modulation der Konzentrationen im einem Sollzustand derart erfolgt, dass eine bestimmte Modulation (Soll-Modulation) oder keine Modulation der gemessenen Leitfähigkeit der Mischlösung oder des mit der Leitfähigkeit korrelierten Parameters der Mischlösung auftritt.According to the invention it is provided inter alia that the conveying means are operated such that a modulation of the concentration of the first and the second component takes place and that measured at least one, preferably at exactly one measuring point, the conductivity of the mixed solution or a correlated with the conductivity parameters of the mixed solution is, wherein the modulation of the concentrations in a desired state such that a certain modulation (target modulation) or no modulation of the measured conductivity of the mixed solution or the conductivity-correlated parameter of the mixed solution occurs.
Der vorliegenden Erfindung liegt somit der Gedanke zugrunde, die Komponenten, wie z.B. das basische Konzentrat und das saure Konzentrat so zu fördern, dass die Konzentrationen der ersten Komponente und die der zweiten Komponente in der Mischlösung über die Zeit veränderlich sind.The present invention is therefore based on the idea to promote the components, such as the basic concentrate and the acidic concentrate so that the concentrations of the first component and the second component in the mixed solution are variable over time.
Diese Modulation der wenigstens zwei Komponenten kann so vorgenommen werden, dass die Summenleitfähigkeit bzw. die damit korrelierte Summenkonzentration, d.h. die Leitfähigkeit oder die Konzentration der Mischlösung keine Modulation aufweist, d.h. zeitlich konstant ist oder eine ganz bestimmte Soll-Modulation aufweist.This modulation of the at least two components can be made such that the sum conductivity or the sum concentration correlated therewith, i. the conductivity or concentration of the mixed solution has no modulation, i. is constant in time or has a very specific desired modulation.
Wird im Rahmen der Auswertung der gemessenen Leitfähigkeit der Mischlösung oder eines damit korrelierten Parameters, wie z.B. der Summenkonzentration der Mischlösung festgestellt, dass diese moduliert ist oder hinsichtlich ihrer Modulation von der bestimmten Soll-Modulation abweicht, kann auf einen Fehlerzustand geschlossen werden. Dieser kann beispielsweise darin bestehen, dass eine oder beide Komponenten mit zu hoher oder mit zu geringer Konzentration in der Mischlösung vorliegen.Used as part of the evaluation of the measured conductivity of the mixed solution or a parameter correlated therewith, e.g. the sum concentration of the mixed solution found that this is modulated or deviates in terms of their modulation from the specific target modulation, can be concluded that an error condition. This may be, for example, that one or both components are present in the mixed solution at too high or too low a concentration.
Besonders vorteilhaft ist es, wenn die Modulation der Konzentrationen der ersten und der zweiten Lösung derart vorgenommen wird, dass in der Mischlösung keine zeitlichen Schwankungen der Leitfähigkeit oder der Konzentration oder eines damit korrelierten Parameters auftreten. Wird dann abweichend von diesem Sollzustand festgestellt, dass die Leitfähigkeit oder ein damit korrelierter Parameter moduliert ist, d.h. zeitlich nicht konstant ist, kann auf einen Fehlerzustand geschlossen werden.It is particularly advantageous if the modulation of the concentrations of the first and the second solution is carried out in such a way that no temporal variations in the conductivity or the concentration or a parameter correlated therewith occur in the mixed solution. If, in deviation from this nominal state, it is determined that the conductivity or a parameter correlated therewith is modulated, i. is not constant over time, can be concluded that an error condition.
Dementsprechend kann eine Auswertung des gemessenen Wertes der Mischlösung dahingehend vorgenommen werden, ob eine Modulation dieses Wertes vorliegt. Ist dies der Fall, kann auf einen Fehlerzustand geschlossen werden.Accordingly, an evaluation of the measured value of the mixed solution can be made as to whether there is a modulation of this value. If this is the case, an error condition can be concluded.
Entsprechendes gilt für den Fall, dass eine ganz bestimmte Soll-Modulation der Summenkonzentration, Leitfähigkeit etc. der Mischlösung eingestellt wird, die den Sollzustand darstellt, und sodann festgestellt wird, dass die tatsächliche Modulation von der bestimmten Soll-Modulation abweicht. Auch in diesem Fall kann auf einen Fehlerzustand geschlossen werden.The same applies to the case in which a specific desired modulation of the sum concentration, conductivity etc. of the mixed solution is set, which represents the desired state, and then it is determined that the actual modulation deviates from the determined nominal modulation. Also in this case can be concluded that an error condition.
In einer vorteilhaften Ausgestaltung der Erfindung kann aus der Art des Fehlerzustandes auf die Komponente geschlossen werden, deren Konzentration von dem Erwartungswert abweicht. Somit wird nicht nur allgemein auf einen Fehlerzustand, d.h. auf einem vom Soll-Zustand abweichenden Zustand geschlossen, sondern es kann festgestellt werden, welche der mehreren Komponenten in einer Konzentration vorliegt, die von dem Sollwert abweicht.In an advantageous embodiment of the invention can be inferred from the type of fault condition on the component whose concentration deviates from the expected value. Thus, not only is there generally a fault condition, i. closed on a different state from the desired state, but it can be determined which of the several components is present in a concentration that deviates from the desired value.
An dieser Stelle wird darauf hingewiesen, dass die vorliegende Erfindung nicht auf die Verwendung von genau zwei Lösungen zur Herstellung einer Mischlösung beschränkt ist, sondern dass auch mehr als zwei Lösungen zum Einsatz kommen können.It should be noted that the present invention is not limited to the use of exactly two solutions for producing a mixed solution, but that more than two solutions can be used.
Bei der Mischlösung kann es sich um die fertige, verabreichbare medizinische Lösung, insbesondere Dialyselösung handeln oder auch um eine Lösung, die erst nach der Zugabe einer oder mehrerer weiterer Substanzen zur fertigen medizinischen Lösung, insbesondere Dialyselösung wird.The mixed solution may be the ready-to-use, administrable medical solution, in particular dialysis solution, or even a solution which becomes the finished medical solution, in particular dialysis solution, only after the addition of one or more further substances.
Das erfindungsgemäße Verfahren kann durchgeführt werden, während der Patient nicht mit der Vorrichtung zur Herstellung der Lösung verbunden ist. Von der Erfindung ist auch der Fall umfasst, dass das Verfahren im Sinne einer online-Herstellung der Lösung durchgeführt wird, während der Patient an die Vorrichtung angeschlossen ist.The method according to the invention can be carried out while the patient is not connected to the device for producing the solution. The invention also includes the case that the method is carried out in the sense of an online preparation of the solution while the patient is connected to the device.
Bei der ersten Komponente kann es sich um ein basisches Konzentrat und bei der zweiten Komponente um ein saures Konzentrat handeln. Das basische Konzentrat weist einen pH-Wert > 7 und einen Puffer auf, das saure Konzentrat weist einen pH-Wert von < 7 und eine physiologisch verträgliche Säure auf. Eines oder beide der Konzentrate können Elektrolyte und ggf. ein Osmotikum aufweisen.The first component may be a basic concentrate and the second component may be an acidic concentrate. The basic concentrate has a pH of> 7 and a buffer, the acidic concentrate has a pH of <7 and a physiologically acceptable acid. One or both of the concentrates may contain electrolytes and optionally an osmotic agent.
Die vorliegende Erfindung erlaubt die Überwachung der physiologischen Eigenschaften der partiellen Komponenten mit einer einzigen Leitfähigkeitsmesszelle oder mit nur einem einzigen Sensor, der zur Messung der Konzentration oder eines mit dieser bzw. mit der Leitfähigkeit korrelierten Parameters geeignet ist. Zudem kann diese Zelle bzw. der Sensor zur Überwachung der Leitfähigkeit oder der Konzentration der Mischlösung verwendet werden.The present invention allows the monitoring of the physiological properties of the partial components with a single conductivity cell or with a single sensor used to measure the concentration or a is suitable with this or with the conductivity correlated parameter. In addition, this cell or the sensor can be used to monitor the conductivity or the concentration of the mixed solution.
Somit besteht eine vorteilhafte Ausgestaltung der Erfindung darin, dass keine Messung der Leitfähigkeit oder eines mit der Leitfähigkeit korrelierten Parameters der ersten oder der zweiten Komponente vorgenommen wird, sondern nur die Erfassung eines Parameters, insbesondere der Leitfähigkeit der Mischlösung.Thus, an advantageous embodiment of the invention is that no measurement of the conductivity or a correlated with the conductivity parameter of the first or the second component is made, but only the detection of a parameter, in particular the conductivity of the mixed solution.
Vorzugsweise ist keine serielle Förderung der Komponenten an der Messstelle vorbei vorgesehen, da in einer bevorzugten Ausgestaltung der Erfindung auf die fehlerhaft vorliegende Komponente aus der gemessenen Eigenschaft der Mischlösung geschlossen werden kann.Preferably, no serial delivery of the components is provided at the measuring point, since in a preferred embodiment of the invention the faulty component can be deduced from the measured property of the mixed solution.
Vorzugsweise ist vorgesehen, dass aus einem oder mehreren der folgenden Parameter ermittelt werden kann, welche Komponente hinsichtlich ihrer Konzentration von dem Erwartungswert für diese Komponente abweicht:
- Amplitude der Modulation der gemessenen Leitfähigkeit der Mischlösung oder des mit der Leitfähigkeit korrelierten gemessenen Parameters der Mischlösung,
- mittlere gemessene Leitfähigkeit der Mischlösung oder Mittelwert des mit der Leitfähigkeit korrelierten gemessenen Parameters der Mischlösung,
- Phasenverschiebung der Modulation der gemessenen Leitfähigkeit der Mischlösung oder des mit der Leitfähigkeit korrelierten gemessenen Parameters der Mischlösung gegenüber der Anregung des Fördermittels.
- The amplitude of the modulation of the measured conductivity of the mixed solution or of the conductivity-correlated measured parameter of the mixed solution,
- mean measured conductivity of the mixed solution or mean value of the conductivity-correlated measured parameter of the mixed solution,
- Phase shift of the modulation of the measured conductivity of the mixed solution or of the measured parameter of the mixed solution correlated with the conductivity compared to the excitation of the conveyor.
Für die letztgenannte Alternative wird somit die Anregung des Aktuators bzw. des Fördermittels für die Komponente erfasst, der/das vorzugsweise als Pumpe ausgeführt ist.For the latter alternative, therefore, the excitation of the actuator or the conveying means for the component is detected, which / is preferably designed as a pump.
Erfindungsgemäß erfolgt die Modulation der Konzentrationen der ersten und der zweiten Komponente sinusförmig.According to the invention, the modulation of the concentrations of the first and second components is sinusoidal.
Die vorliegende Erfindung betrifft des Weiteren eine Vorrichtung zur Herstellung einer medizinischen Lösung, wobei die Vorrichtung wenigstens ein erstes Fördermittel zur Förderung einer ersten Komponente und wenigstens ein zweites Fördermittel zur Förderung einer zweiten Komponente aufweist sowie wenigstens eine Hauptleitung, die mit den Fördermitteln derart in Verbindung steht, dass die Komponenten durch die Fördermittel in die Hauptleitung gefördert werden, so dass in der Hauptleitung zumindest eine Mischlösung entsteht, wobei wenigstens ein, vorzugsweise genau ein Sensor zur Messung der Leitfähigkeit oder eines mit der Leitfähigkeit korrelierten Parameters der Mischlösung in der Hauptleitung vorgesehen ist und dass die Fördermittel so ausgebildet sind, dass eine Modulation der Konzentrationen im einem Sollzustand der Vorrichtung derart erfolgt, dass eine bestimmte Soll-Modulation oder keine Modulation der gemessenen Leitfähigkeit der Mischlösung oder des mit der Leitfähigkeit korrelierten gemessenen Parameters der Mischlösung auftritt.The present invention further relates to a device for producing a medical solution, wherein the device has at least one first conveying means for conveying a first component and at least one second conveying means for conveying a second component and at least one main line, which is in communication with the conveying means in that the components are conveyed by the conveying means into the main line so that at least one mixed solution is formed in the main line, at least one, preferably exactly one, sensor for measuring the conductivity or a parameter of the mixed solution correlated with the conductivity being provided in the main line and that the conveying means are designed so that a modulation of the concentrations in a nominal state of the device takes place in such a way that a certain desired modulation or no modulation of the measured conductivity of the mixed solution or with the Leitf ability correlated measured parameter of the mixed solution occurs.
Vorzugsweise weist die Vorrichtung wenigstens eine Auswerteeinheit auf, die mit dem Sensor in Verbindung steht und die das von dem Sensor erfasste Signal auswertet, wobei die Auswerteeinheit derart ausgebildet ist, dass auf einen Fehlerzustand geschlossen wird, wenn eine Modulation oder eine von der Soll-Modulation abweichende Modulation der gemessenen Leitfähigkeit der Mischlösung oder des mit der Leitfähigkeit korrelierten gemessenen Parameters der Mischlösung festgestellt wird.Preferably, the device has at least one evaluation unit, which is in communication with the sensor and which evaluates the signal detected by the sensor, wherein the evaluation unit is designed such that an error state is concluded when a modulation or one of the desired modulation deviating modulation of the measured conductivity of the mixed solution or of the conductivity-correlated measured parameter of the mixed solution is detected.
Die Auswerteeinheit kann derart ausgebildet sein, dass aus der Art des Fehlerzustandes ermittelbar ist, welche Komponente hinsichtlich ihrer Konzentration von dem Erwartungswert abweicht.The evaluation unit may be designed in such a way that it is possible to determine from the type of error state which component deviates from the expected value in terms of its concentration.
Wie oben ausgeführt, ist vorzugsweise genau ein Sensor zur Messung der Leitfähigkeit oder eines mit der Leitfähigkeit korrelierten Parameters der Mischlösung vorgesehen.As stated above, it is preferable to provide precisely one sensor for measuring the conductivity or a parameter of the mixed solution correlated with the conductivity.
Auf Sensoren zur Messung der individuellen Leitfähigkeit oder eines mit der Leitfähigkeit korrelierten individuellen Parameters der ersten oder der zweiten Komponente wird vorzugsweise verzichtet.Sensors for measuring the individual conductivity or a conductivity-correlated individual parameter of the first or the second component are preferably dispensed with.
Die Auswerteeinheit ist vorzugsweise derart ausgebildet, dass aus der Amplitude der Modulation der gemessenen Leitfähigkeit oder des mit der Leitfähigkeit korrelierten Parameters und/oder aus der mittleren gemessenen Leitfähigkeit oder aus dem Mittelwert des mit der Leitfähigkeit korrelierten Parameters und/oder aus der Phasenverschiebung der Modulation der gemessenen Leitfähigkeit oder des mit der Leitfähigkeit korrelierten Parameters gegenüber der Anregung des Fördermittels bestimmt wird, welche Komponente hinsichtlich ihrer Konzentration von dem Erwartungswert für diese Komponente abweicht.The evaluation unit is preferably designed such that from the amplitude of the modulation of the measured conductivity or of the parameter correlated with the conductivity and / or from the average measured conductivity or from the mean value of the parameter correlated with the conductivity and / or from the phase shift of the modulation measured conductivity or the correlated with the conductivity parameter with respect to the excitation of the conveyor is determined, which component differs in concentration from the expected value for this component.
Für den Vergleich mit der Modulation des Fördermittels ist ein entsprechender Sensor oder ein sonstiges Erfassungsmittel vorgesehen, der diese Modulation, d.h. die Anregung der Pumpe oder dergleichen erfasst.For comparison with the modulation of the conveyor means, a corresponding sensor or other detection means is provided which controls this modulation, i. detects the excitation of the pump or the like.
Erfindungsgemäß erfolgt die Modulation der Konzentration der ersten und der zweiten Komponente sinusförmig.According to the invention, the modulation of the concentration of the first and the second component is sinusoidal.
Die vorliegende Erfindung betrifft des Weiteren eine Blutbehandlungsvorrichtung, insbesondere eine Dialysemaschine, vorzugsweise zur Durchführung einer Hämodialysebehandlung, wobei die Blutbehandlungsvorrichtung wenigstens eine erfindungsgemäße Vorrichtung zur Herstellung der medizinischen Lösung aufweist.The present invention further relates to a blood treatment device, in particular a dialysis machine, preferably for performing a hemodialysis treatment, wherein the blood treatment device comprises at least one device according to the invention for the preparation of the medical solution.
Weitere Einzelheiten und Vorteile der Erfindung werden anhand eines in der Zeichnung dargestellten Ausführungsbeispiels näher erläutert. Es zeigen:
- Figur 1:
- die Summenleitfähigkeit der Komponenten A und B sowie den Beitrag der Einzelleitfähigkeiten der Komponenten A und B zur Summenleitfähigkeit,
- Figur 2:
- die Summenleitfähigkeit der Komponenten A und B sowie den Beitrag der Einzelleitfähigkeiten der Komponenten A und B zur Summenleitfähigkeit für vier verschiedene Zustände A bis C und
- Figur 3:
- eine schematische Ansicht eines Multikomponentensystems umfassend die
Komponenten 1 bis N mit einer Leitfähigkeitsmesszelle zur Messung der Summenleitfähigkeit der Mischlösung.
- FIG. 1:
- the sum conductivity of components A and B as well as the contribution of the individual conductivity of components A and B to the sum conductivity,
- FIG. 2:
- the sum conductivity of the components A and B and the contribution of Einzelleitfähigkeiten the components A and B to the total conductivity for four different states A to C and
- FIG. 3:
- a schematic view of a multi-component system comprising the
components 1 to N with a conductivity measuring cell for measuring the total conductivity of the mixed solution.
Aus
Das Ausführungsbeispiel bezieht sich auf die Messung der Leitfähigkeit und ist auch für die Messung jedes anderen Parameters denkbar. Die Erfindung umfasst somit auch die Messung jedes anderen Parameters der Mischlösung, der mit der Leitfähigkeit bzw. mit der Konzentration korreliert, so dass ein Rückschluss auf die Konzentration der Komponenten A und/oder B bzw. auf deren Inhaltsstoffe gezogen werden kann.The embodiment relates to the measurement of the conductivity and is also conceivable for the measurement of any other parameter. The invention thus also encompasses the measurement of each other parameter of the mixed solution, which correlates with the conductivity or with the concentration, so that a conclusion can be drawn on the concentration of the components A and / or B or on their ingredients.
Aus
Die Förderung der partiellen Komponenten A und B erfolgt in dem in
Die Amplitude der Konzentrations- bzw. Leitfähigkeitsschwankungen, die in
Geht man davon aus, dass die partiellen Komponenten, d.h. die Komponenten A und B, die die Mischlösung bilden bzw. in dieser ggf. in einem Lösungsmittel, wie insbesondere Wasser vorliegen, in der Mischlösung die Konzentrationen CA und CB aufweisen und die Einzelleitfähigkeiten bzw. Leitfähigkeitsbeiträge der Komponenten A und B in der Mischlösung LFA(t) und LFB(t) sind, ergibt sich bei den relativen Amplituden fA und fB und einer ω-Modulation für den zeitlichen Verlauf der Leitfähigkeiten:
Die relative Amplitude ist der Quotient aus der absoluten Amplitude der Konzentrationsschwankung und dem Mittelwert der Konzentration der Komponente A bzw. B in der Mischlösung.The relative amplitude is the quotient of the absolute amplitude of the concentration fluctuation and the mean value of the concentration of component A or B in the mixed solution.
Aus der vorzugsweise angestrebten Freiheit von Modulationen der Summenkonzentration bzw. der Summenleitfähigkeit über die Zeit ergibt sich:
Legt man die relative Amplitude der Modulation der Komponente B z.B. auf den Wert 0,5 ergibt sich weiter:
Damit ergibt sich die relative Amplitude fA der Komponente A unmittelbar aus dem angestrebten Verhältnis der Konzentrationen der Komponenten B und A in der Mischlösung und der relativen Amplitude fB der Komponente B.Thus, the relative amplitude f A of the component A results directly from the desired ratio of the concentrations of the components B and A in the mixed solution and the relative amplitude f B of the component B.
Die gemessene Summenleitfähigkeit, d.h. die Leitfähigkeit der aus dem Einzelkomponenten A und B zusammengesetzten Mischlösung wird im Sollzustand den gewünschten physiologischen Erwartungswert aufweisen bzw. mit der erwarteten Summenkonzentration, d.h. der Summe der Konzentration der Einzelkomponenten A und B korrelieren. Für das oben genannte Beispiel mit fB = 0,5 ergibt sich dann aus den Gleichungen (1), (2) und (5):
Die Erwartungswerte CA und CB in der Mischlösung sind zeitlich konstant, so dass sich auch hinsichtlich der Summenleitfähigkeit LFA(t) + LFB(t) eine zeitliche Konstanz ergibt.The expected values C A and C B in the mixed solution are constant in time, so that there is also a temporal constancy with regard to the sum conductivity LF A (t) + LF B (t).
Weicht der Beitrag einer Komponente A oder B von dem jeweiligen Erwartungswert ab, kommt es zu einer Modulation der Summenleitfähigkeit. Je nachdem, welche Komponente hinsichtlich der Konzentration von dem Erwartungswert abweicht, wird eine bestimmte Modulation der Summenleitfähigkeit erzeugt, d.h. die Messung der Summenleitfähigkeit erzeugt einen charakteristischen Fingerabdruck. Somit kann anhand der Messung der Summenleitfähigkeit festgestellt werden, welche Komponente vom Erwartungswert abweicht.If the contribution of a component A or B deviates from the respective expected value, the sum conductivity is modulated. Depending on which component deviates in terms of concentration from the expected value, a certain modulation of the sum conductivity is generated, ie the measurement of the Total conductivity produces a characteristic fingerprint. Thus, it can be determined based on the measurement of the sum conductivity, which component deviates from the expected value.
Geht man davon aus, dass die Komponente B hinsichtlich ihrer Konzentration in der Mischlösung nicht dem Erwartungswert CB entspricht, sondern nur den Wert CB' aufweist, der einen bestimmten Bruchteil 1/α des Erwartungswertes CB darstellt, ergibt sich:
Die Summenleitfähigkeit weist somit in diesem Fall nicht den sich aus Gleichung (6) ergebenden Wert auf, sondern ergibt sich unter Berücksichtigung von Gleichung (5) und (7) zu:
Weicht somit der Komponentenbeitrag der Komponente B um den Faktor 1/α vom Erwartungswert ab, so moduliert die Leitfähigkeit der Summenkonzentration, d.h. der Mischlösung aus den beiden Komponenten A und B in diesem Ausführungsbeispiel mit der Amplitude (1/α - 1) CB/2.If the component contribution of component B thus deviates from the expected value by a factor of 1 / α, then the conductivity of the sum concentration, ie the mixed solution of the two components A and B modulates the amplitude (1 / α-1) C B / in this exemplary embodiment. second
Die mittlere Summenleitfähigkeit entspricht bzw. korreliert in diesem Fall mit CA + 1/α CB.The mean sum conductivity corresponds or correlates in this case with C A + 1 / α C B.
Geht man davon aus, dass die Komponente A hinsichtlich ihrer Konzentration nicht dem Erwartungswert CA entspricht, sondern nur den Wert CA' aufweist, der einen bestimmten Bruchteil 1/β des Erwartungswertes CA darstellt, ergibt sich:
Die Summenleitfähigkeit weist somit in diesem Fall nicht den sich aus Gleichung (6) ergebenden Wert auf, sondern ergibt sich unter Berücksichtigung von Gleichung (5) und (10) zu:
Weicht somit der Komponentenbeitrag der Komponente A um den Faktor 1/β vom Erwartungswert ab, so moduliert die Leitfähigkeit der Summenkonzentration, d.h. der Mischlösung aus den beiden Komponenten A und B in diesem Ausführungsbeispiel mit der Amplitude (1 - 1/β) CB/2.If the component contribution of component A deviates by the
Die mittlere Summenleitfähigkeit entspricht bzw. korreliert in diesem Fall mit 1/β CA + CB.The mean sum conductivity corresponds or correlates with 1 / β C A + C B in this case.
Die mittlere Leitfähigkeit, deren Amplitude und die Phase gegenüber der Aktuatoranregung der Komponentenförderung identifizieren die Komponente, deren Konzentration von dem Erwartungswert abweicht.The average conductivity, its amplitude, and the phase versus actuator excitation of the component promotion identify the component whose concentration deviates from the expected value.
Leisten die Komponenten zur Summenkonzentration einen unterschiedlichen Beitrag, kann auch eine sich kompensierende Abweichung unter den Komponenten identifiziert werden.If the components make a different contribution to the sum concentration, a compensating deviation among the components can also be identified.
In dem Zustand B ist der Erwartungswert 20 der Komponente B erreicht, jedoch ist der tatsächliche Wert der Konzentration 10 der Komponente A unter dem Erwartungswert. Die Summenleitfähigkeit 100 bzw. die Summenkonzentration liegt unter dem Erwartungswert und ist phasenverschoben moduliert mit der abweichenden Komponente A.In state B, the expected
In dem Zustand C ist der Erwartungswert 10 der Komponente A erreicht, jedoch ist der tatsächliche Wert der Konzentration 20 der Komponente B unter dem Erwartungswert. Die Summenleitfähigkeit 100 bzw. die Summenkonzentration liegt unter dem Erwartungswert und ist phasenverschoben moduliert mit der abweichenden Komponente B.In the state C, the expected
In dem Zustand D sind beide Erwartungswerte der Komponenten A und B nicht erreicht. Die Abweichung ist jedoch kompensatorisch, d.h. der Summenbeitrag entspricht dem Erwartungswert, d.h. der Mittelwert der Summenleitfähigkeit 100 bzw. der Summenkonzentration entspricht dem Erwartungswert.In state D, both expected values of components A and B are not reached. The deviation, however, is compensatory, i. the sum contribution corresponds to the expected value, i. the mean value of the
Allerdings ist auch in diesem Fall die Summenleitfähigkeit 100 bzw. die Summenkonzentration moduliert, d.h. zeitlich nicht konstant.However, in this case too, the
Eine Abweichung der Konzentrationsbeiträge der Komponenten A und B lässt sich somit aus der Analyse der modulierten Summenkonzentration bzw. Summenleitfähigkeit vornehmen.A deviation of the concentration contributions of the components A and B can thus be made from the analysis of the modulated sum concentration or sum conductivity.
Aus dieser Analyse ergibt sich die Phasenverschiebung der Modulation der Summenkonzentration bzw. der Summenleitfähigkeit gegenüber den Phasen der Konzentratförderpumpen.From this analysis results the phase shift of the modulation of the sum concentration or the sum conductivity compared to the phases of the concentrate feed pumps.
Der mittlere Erwartungswert der Summenkonzentration bzw. der Summenleitfähigkeit weist auf eine Über- oder Unterförderung der abweichenden Komponente hin, d.h. der gemessene Mittelwert der Summenleitfähigkeit oder der Summenkonzentration weist auf eine Über- oder Unterförderung der abweichenden Komponente hin.The mean expected value of the sum concentration or the sum conductivity indicates an over or under promotion of the deviating component, i. the measured average of the sum conductivity or the sum concentration indicates an over- or under-promotion of the deviating component.
So lässt sich beispielsweise aus dem Zustand B in
Über die Ermittlung der Phasenverschiebung der Amplitude der Summenleitfähigkeit oder der Summenkonzentration zur Phase der Konzentratförderpumpe kann selbst eine kompensatorische Abweichung der Komponenten ermittelt werden, die nicht zu einer Änderung der mittleren Summenleitfähigkeit oder Summenkonzentration führt.By determining the phase shift of the amplitude of the sum conductivity or the sum concentration to the phase of the concentrate feed pump, even a compensatory deviation of the components can be determined, which does not lead to a change in the average sum conductivity or sum concentration.
Erfindungsgemäß ist für die Überwachung der Beiträge der einzelnen, d.h. der partiellen Komponenten lediglich ein einzelner bzw. ein einziger Leitfähigkeits- oder Konzentrationssensor oder dergleichen erforderlich. Die Komponenten werden über moduliert fördernde Konzentratpumpen der Hauptleitung zugegeben, in der sich der Sensor befindet.According to the invention, for monitoring the contributions of the individual, i. the partial components only a single or a single conductivity or concentration sensor or the like required. The components are added via modulated conveying concentrate pumps to the main line, in which the sensor is located.
Anstatt eines Leitfähigkeitssensors oder eines Konzentrationssensors kann auch jeder andere Sensor verwendet werden, der einen Rückschluss auf die Konzentrationen oder Leifähigkeiten der Komponenten bzw. auf die Summenkonzentration oder auf die Summenleitfähigkeit erlaubt.Instead of a conductivity sensor or a concentration sensor, any other sensor can be used, which inferences on the concentrations or Leifähigkeiten the components or on the cumulative concentration or on the total conductivity allowed.
Claims (13)
- A method for preparing a medical solution from at least one first component and at least one second component, wherein
the first component and the second component are present as liquids and are respectively conveyed by a conveying means to obtain a mixed solution,
the conveying means are operated such that a modulation of the concentrations of the first and second components takes place,
at a measurement point the conductivity or a parameter of the mixed solution correlating with the conductivity is measured, and
the modulation of the concentrations of the components takes place in a desired state such that a specific desired modulation or no modulation of the measured conductivity or of the parameter of the mixed solution correlated with the conductivity occurs,
characterized in that
the modulation of the first and the second component takes place continuously sinusoidal. - The method in accordance with claim 1, characterized in that an evaluation of the measured conductivity or of the measured value of the parameter of the mixed solution correlated with the conductivity is carried out and a conclusion is drawn on an error state upon occurrence of a modulation or a deviation from the desired modulation.
- The method in accordance with one of the preceding claims, characterized in that the medical solution is a dialysis solution; and/or in that the first component is a base concentrate and the second component is an acid concentrate.
- The method in accordance with one of the preceding claims, characterized in that no measurement of the conductivity or of a parameter correlated with the conductivity of the first or second component is carried out.
- The method in accordance with one of the preceding claims, characterized in that no serial conveying of the components past the measurement point takes place.
- The method in accordance with one of the preceding claims, characterized in that a determination is made from the amplitude of the modulation of the measured conductivity of the mixed solution or of the measured parameter of the mixed solution correlated with the conductivity of the mixed solution and/or from the mean measured conductivity of the mixed solution or from the mean value of the measured parameter of the mixed solution correlated with the conductivity and/or from the phase shift of the modulation of the measured conductivity of the mixed solution or of the measured parameter of the mixed solution correlated with the conductivity in relation to the stimulation of the conveying means, as to which component deviates in its concentration from the expected value for this component.
- A device for producing a medical solution, comprising:a first conveying means for conveying a first component,a second conveying means for conveying a second component, as well asa main line which is in communication with the conveying means such that the components are conveyed into the main line by the conveying means so that a mixed solution is created in the main line, whereina sensor is provided in the main line for measuring the conductivity or of a parameter of the mixed solution correlated with the conductivity, andthe conveying means are configured such that a modulation of the concentrations of the components takes place in a desired state such that no modulation or a specific desired modulation of the measured conductivity or of the parameter of the mixed solution correlated with the conductivity occurs,characterized in thatthe conveying means are configured such that the modulation of the concentrations of the first and the second components takes place continuously sinusoidal.
- The device in accordance with claim 7, characterized in that the device comprises an evaluation unit to which the signal detected by the sensor is supplied, wherein the evaluation unit is configured such that an error state is concluded when a modulation or a modulation of the measured conductivity or of the parameter of the mixed solution correlated with the conductivity deviating from the desired modulation is detected.
- The device in accordance with claim 8, characterized in that the evaluation unit is configured such that it can be determined from the kind of error state which component deviates with respect to its concentration from the expected value for this component.
- The device in accordance with one of the claims 7 to 9, characterized in that exactly one sensor is provided for measuring the conductivity or a parameter of the mixed solution correlated with the conductivity.
- The device in accordance with one of the claims 7 to 10, characterized in that no sensor is provided for measuring the conductivity or a parameter of the first or the second components correlated with the conductivity.
- The device in accordance with one of the claims 7 to 11, characterized in that an evaluation unit is configured such thata determination is made from the amplitude of the modulation of the measured conductivity of the mixed solution or of the measured parameter of the mixed solution correlated with the conductivity and/or from the mean measured conductivity of the mixed solution or from the mean value of the measured parameter of the mixed solution correlated with the conductivity and/or from the phase shift of the modulation of the measured conductivity of the mixed solution or of the measured parameter of the mixed solution correlated with conductivity in relation to the stimulation of the conveying means, as to which component deviates in its concentration from the expected value for this component.
- A blood treatment device, in particular a dialysis machine, having a device in accordance with one of the claims 7 to 12.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP19187803.2A EP3574936B1 (en) | 2015-04-22 | 2016-04-15 | Method and device for the production of a medical solution |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102015005142.3A DE102015005142A1 (en) | 2015-04-22 | 2015-04-22 | Method and device for producing a medical solution |
PCT/EP2016/000625 WO2016169642A1 (en) | 2015-04-22 | 2016-04-15 | Method and device for producing a medical solution |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19187803.2A Division EP3574936B1 (en) | 2015-04-22 | 2016-04-15 | Method and device for the production of a medical solution |
EP19187803.2A Division-Into EP3574936B1 (en) | 2015-04-22 | 2016-04-15 | Method and device for the production of a medical solution |
Publications (2)
Publication Number | Publication Date |
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EP3285825A1 EP3285825A1 (en) | 2018-02-28 |
EP3285825B1 true EP3285825B1 (en) | 2019-10-16 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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EP19187803.2A Active EP3574936B1 (en) | 2015-04-22 | 2016-04-15 | Method and device for the production of a medical solution |
EP16720711.7A Active EP3285825B1 (en) | 2015-04-22 | 2016-04-15 | Method and device for producing a medical solution |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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EP19187803.2A Active EP3574936B1 (en) | 2015-04-22 | 2016-04-15 | Method and device for the production of a medical solution |
Country Status (7)
Country | Link |
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US (1) | US10940255B2 (en) |
EP (2) | EP3574936B1 (en) |
JP (1) | JP6804466B2 (en) |
CN (1) | CN107530482B (en) |
BR (1) | BR112017022686B1 (en) |
DE (1) | DE102015005142A1 (en) |
WO (1) | WO2016169642A1 (en) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102017109127A1 (en) * | 2017-04-27 | 2018-10-31 | B. Braun Avitum Ag | Method and device for the intermittent, pulsating proportioning of a dialysis fluid mixture |
DE102018121080A1 (en) * | 2018-08-29 | 2020-03-05 | B. Braun Avitum Ag | Method and device for intermittent, pulsating proportioning of a dialysis fluid mixture |
DE102018010174A1 (en) * | 2018-12-31 | 2020-07-02 | Fresenius Medical Care Deutschland Gmbh | Device and method for producing a dialysis solution |
Family Cites Families (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3416057A1 (en) * | 1984-04-30 | 1985-10-31 | Fresenius AG, 6380 Bad Homburg | HAEMODIALYSIS DEVICE |
US5486286A (en) * | 1991-04-19 | 1996-01-23 | Althin Medical, Inc. | Apparatus for performing a self-test of kidney dialysis membrane |
US6139754A (en) * | 1991-11-15 | 2000-10-31 | Baxter International Inc. | Hemodialysis conductivity servo-proportioning system and method |
US6691040B2 (en) * | 1999-12-02 | 2004-02-10 | Hospal Ag | Method for determining a parameter indicative of the progress of an extracorporeal blood treatment |
CA2687682C (en) * | 2007-05-29 | 2017-10-31 | Fresenius Medical Care Holdings, Inc. | Solutions, dialysates, and related methods |
US7905855B2 (en) * | 2007-07-05 | 2011-03-15 | Baxter International Inc. | Dialysis system having non-invasive temperature sensing |
CN102378636B (en) * | 2009-03-31 | 2014-09-17 | 弗雷森纽斯医疗护理德国有限责任公司 | Device and method for determining and controlling the concentration of at least one solute in a fluid circuit |
JP5423318B2 (en) | 2009-10-29 | 2014-02-19 | ニプロ株式会社 | Dialysate concentration monitoring device and operating method thereof |
ITMI20110441A1 (en) * | 2011-03-21 | 2012-09-22 | Gambro Lundia Ab | EQUIPMENT FOR EXTRACORPROUS TREATMENT OF BLOOD. |
DE102012007412B4 (en) * | 2012-04-16 | 2023-09-28 | Fresenius Medical Care Deutschland Gmbh | Methods and devices for modulating the operating point of liquid pumps in medical treatment devices |
EP2732834B1 (en) * | 2012-11-14 | 2015-07-29 | Gambro Lundia AB | Apparatus for determining a parameter indicative of the progress of an extracorporeal blood treatment |
US10905816B2 (en) * | 2012-12-10 | 2021-02-02 | Medtronic, Inc. | Sodium management system for hemodialysis |
WO2014173747A1 (en) * | 2013-04-25 | 2014-10-30 | Gambro Lundia Ab | System and method for preparation of a medical fluid |
US9731059B2 (en) * | 2013-07-02 | 2017-08-15 | Fresenius Medical Care Holdings, Inc. | Sensor and method of sensing for dialysis machine |
DE102013218771B3 (en) * | 2013-09-19 | 2014-09-18 | Siemens Aktiengesellschaft | Method and gas analyzer for measuring the concentration of a gas component in a sample gas |
DE102014109369A1 (en) * | 2014-07-04 | 2016-01-07 | B. Braun Avitum Ag | dialysis machine |
-
2015
- 2015-04-22 DE DE102015005142.3A patent/DE102015005142A1/en not_active Withdrawn
-
2016
- 2016-04-15 BR BR112017022686-3A patent/BR112017022686B1/en active IP Right Grant
- 2016-04-15 US US15/568,355 patent/US10940255B2/en active Active
- 2016-04-15 EP EP19187803.2A patent/EP3574936B1/en active Active
- 2016-04-15 WO PCT/EP2016/000625 patent/WO2016169642A1/en active Application Filing
- 2016-04-15 EP EP16720711.7A patent/EP3285825B1/en active Active
- 2016-04-15 JP JP2017555299A patent/JP6804466B2/en active Active
- 2016-04-15 CN CN201680023129.1A patent/CN107530482B/en active Active
Non-Patent Citations (1)
Title |
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None * |
Also Published As
Publication number | Publication date |
---|---|
EP3574936B1 (en) | 2021-06-02 |
JP6804466B2 (en) | 2020-12-23 |
US10940255B2 (en) | 2021-03-09 |
EP3574936A1 (en) | 2019-12-04 |
CN107530482A (en) | 2018-01-02 |
US20180140762A1 (en) | 2018-05-24 |
BR112017022686A2 (en) | 2018-07-10 |
WO2016169642A1 (en) | 2016-10-27 |
CN107530482B (en) | 2020-11-03 |
JP2018516632A (en) | 2018-06-28 |
DE102015005142A1 (en) | 2016-10-27 |
BR112017022686B1 (en) | 2022-09-20 |
EP3285825A1 (en) | 2018-02-28 |
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